Alendronate Sodium

Product NDC
61919-729
11-digit product format
619190729
Labeler code
61919
Product ID
61919-729_7fbca6be-aab0-19d4-e053-2991aa0a72eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA076768
Marketing category
ANDA
Marketing start
2019-01-18
Marketing end
0000-00-00
Substance
ALENDRONATE SODIUM
Active strength
35 mg/1
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b55122e7-1795-3be6-8216-d42256d80e7dProduct name220250224
c3d77bcb-5cf1-4ea6-9307-38d8932a8b0aProduct name120240513
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
c00e0569-fbc4-d31d-3ec8-d316fcedaffcProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-729-042025-01-30C16284748780-12cef2736-b00f-d83d-e063-dadaa90ab31fAlendronate Sodium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-729-04Alendronate Sodium4 in 1 BOTTLETABLET41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-729-04EA - Each61919-729b60e40fd-f982-40f7-b14a-0da1c90a438612019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-729ALENDRONATE SODIUM TABLET [DIRECT_RX]1Legacy NDC, 1 package rows20190119_7fbca6be-aaaf-19d4-e053-2991aa0a72eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSN7fbca6be-aaaf-19d4-e053-2991aa0a72eb1
904396alendronic acid 35 MG Oral TabletSCD7fbca6be-aaaf-19d4-e053-2991aa0a72eb1
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY7fbca6be-aaaf-19d4-e053-2991aa0a72eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-729-04619190729044 TABLET in 1 BOTTLE (61919-729-04) 4 tablet2019-01-180000-00-00NoNoCurrent